FDA applicant
Paige.Ai, Inc.
FDA records 3 decisions for Paige.Ai, Inc. (New York, NY) from 2020 to 2025: 2 510(k) clearances and 1 De Novo grant. Most are in product codes QKQ (Digital Pathology Image Viewing And Management…) and QPN (Software Algorithm Device To Assist Users In…). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Paige.Ai”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Paige.Ai, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Paige.Ai, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report